External energy transfer system for an implantable medical device and method therefor

ABSTRACT

User interface for external power source, recharger, for an implantable medical device. At least some of patient controls and display icons of an energy transfer unit are common with at least some of the patient controls and the display icons of a patient control unit. An energy transfer unit is operable by the patient with less than three operative controls to control energy transfer from the external energy transfer unit to the implantable medical device. An external antenna having a primary coil can inductively transfer energy to a secondary coil of the implantable medical device when the external antenna is externally placed in proximity of the secondary coil. An energy transfer unit has an external telemetry coil allowing the energy transfer unit to communicate with the implantable medical device through the internal telemetry coil in order to at least partially control the therapeutic output of the implantable medical device.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/704,728 filed on Sep. 14, 2017, which is a continuation of U.S. Pat.No. 9,789,324, which is a divisional application of U.S. Pat. No.9,259,584, which is a divisional application of U.S. Pat. No. 8,346,361,which claims priority to U.S. Provisional Application Ser. No.60/508,198, filed Oct. 2, 2003, entitled User Interface for ExternalCharger for Implantable Medical Device, and also claims priority to U.S.Provisional Application Ser. No. 60/513,732, filed Oct. 23, 2003,entitled User Interface for External Charger for Implantable MedicalDevice. The entire contents of all of the foregoing applications arehereby incorporated by reference.

FIELD OF THE INVENTION

This invention relates to implantable medical devices and, inparticular, to energy transfer devices, systems and methods forimplantable medical devices.

BACKGROUND OF THE INVENTION

Implantable medical devices for producing a therapeutic result in apatient are well known. Examples of such implantable medical devicesinclude implantable drug infusion pumps, implantable neurostimulators,implantable cardioverters, implantable cardiac pacemakers, implantabledefibrillators and cochlear implants. Of course, it is recognized thatother implantable medical devices are envisioned which utilize energydelivered or transferred from an external device.

A common element in all of these implantable medical devices is the needfor electrical power in the implanted medical device. The implantedmedical device requires electrical power to perform its therapeuticfunction whether it be driving an electrical infusion pump, providing anelectrical neurostimulation pulse or providing an electrical cardiacstimulation pulse. This electrical power is derived from a power source.

Typically, a power source for an implantable medical device can take oneof two forms. The first form utilizes an external power source thattranscutaneously delivers energy via wires or radio frequency energy.Having electrical wires which perforate the skin is disadvantageous due,in part, to the risk of infection. Further, continuously couplingpatients to an external power for therapy is, at least, a largeinconvenience. The second form utilizes single cell batteries as thesource of energy of the implantable medical device. This can beeffective for low power applications, such as pacing devices. However,such single cell batteries usually do not supply the lasting powerrequired to perform new therapies in newer implantable medical devices.In some cases, such as an implantable artificial heart, a single cellbattery might last the patient only a few hours. In other, less extremecases, a single cell unit might expel all or nearly all of its energy inless than a year. This is not desirable due to the need to explant andre-implant the implantable medical device or a portion of the device.One solution is for electrical power to be transcutaneously transferredthrough the use of inductive coupling. Such electrical power or energycan optionally be stored in a rechargeable battery. In this form, aninternal power source, such as a battery, can be used for directelectrical power to the implanted medical device. When the battery hasexpended, or nearly expended, its capacity, the battery can be rechargedtranscutaneously, via inductive coupling from an external power sourcetemporarily positioned on the surface of the skin.

Transcutaneous energy transfer through the use of inductive couplinginvolves the placement of two coils positioned in close proximity toeach other on opposite sides of the cutaneous boundary. The internalcoil, or secondary coil, is part of or otherwise electrically associatedwith the implanted medical device. The external coil, or primary coil,is associated with the external power source or external charger, orrecharger. The primary coil is driven with an alternating current. Acurrent is induced in the secondary coil through inductive coupling.This current can then be used to power the implanted medical device orto charge, or recharge, an internal power source, or a combination ofthe two.

Since it may be necessary for the patient to operate the external powersource and since the patient may not be medically skilled norelectronically skilled, it is desirable that the external power sourcehave a user interface that is both intuitive and simple to use andoperate.

SUMMARY OF THE INVENTION

In an embodiment, the present invention provides an implantable medicaldevice system. An implantable medical device provides a therapeuticoutput to a patient. An external patient control unit can be operativelycoupled via telemetry with the implantable medical device allowing thepatient to control the therapeutic output of the implantable medicaldevice. An external energy transfer unit can be operatively coupled tothe implantable medical device to transcutaneously transfer energy tothe implantable medical device. The external patient control unit has auser interface operable by the patient having patient controls anddisplay icons indicative of a status of operation of the patient controlunit. The energy transfer unit has a user interface operable by thepatient having patient controls and display icons indicative of a statusof operation of the energy transfer unit. At least some of the patientcontrols and the display icons of the energy transfer unit are commonwith at least some of the patient controls and the display icons of thepatient control unit.

In another embodiment, the present invention provides an external energytransfer unit adapted to transcutaneously transfer energy to animplantable medical device for providing a therapeutic output to apatient. The implantable medical device is capable of communication withan external patient control unit allowing the patient to control thetherapeutic output of the implantable medical device. The externalpatient control unit has a user interface operable by the patient havingpatient controls and display icons indicative of a status of operationof the patient control unit. A user interface operable by the patienthas patient controls and display icons indicative of a status ofoperation of the energy transfer unit. At least some of the patientcontrols and the display icons of the energy transfer unit are commonwith at least some of the patient controls and the display icons of thepatient control unit.

In another embodiment, the present invention provides a method ofproviding therapeutic output to a patient using an implantable medicaldevice. An external patient control unit is operatively coupled viatelemetry with the implantable medical device allowing the patient tocontrol the therapeutic output of the implantable medical device. Anexternal energy transfer unit is operatively coupled to the implantablemedical device to transcutaneously transfer energy to the implantablemedical device. The external patient control unit has a user interfaceoperable by the patient having patient controls and display iconsindicative of a status of operation of the patient control unit. Theenergy transfer unit has a user interface operable by the patient andhas patient controls and display icons indicative of a status ofoperation of the energy transfer unit. At least some of the patientcontrols and the display icons of the energy transfer unit are commonwith at least some of the patient controls and the display icons of thepatient control unit.

In a preferred embodiment, at least one of the display icons is an iconrepresentative of a state of charging of an energy storage device in theimplantable medical device.

In a preferred embodiment, at least one of the patient controls is acontrol for adjusting the therapeutic output of the implantable medicaldevice.

In a preferred embodiment, the external energy transfer unit inductivelycouples energy to the implantable medical device.

In a preferred embodiment, the implantable medical device has arechargeable energy storage device and wherein the energy transfer unitcharges the rechargeable energy storage device.

In another embodiment, the present invention provides an implantablemedical device system. An implantable medical device provides atherapeutic output to a patient. An external energy transfer unit can beoperatively coupled to transcutaneously transfer energy to theimplantable medical device. The energy transfer unit is operable by thepatient with less than three operative controls to control energytransfer from the external energy transfer unit to the implantablemedical device.

In another embodiment, the present invention provides an external energytransfer unit adapted to transcutaneously transfer energy to animplantable medical device for providing a therapeutic output to apatient. Energy transfer circuitry transcutaneously transfers energy tothe implantable medical device. Less than three operative controlscontrol energy transfer from the external energy transfer unit to theimplantable medical device.

In another embodiment, the present invention provides a method providinga therapeutic output to a patient with an implantable medical device. Anexternal energy transfer unit is operatively coupled with theimplantable medical device to transcutaneously transfer energy to theimplantable medical device. The energy transfer unit is controlled withless than three operative controls to control energy transfer from theexternal energy transfer unit to the implantable medical device.

In a preferred embodiment, the energy transfer unit is operable with twooperative controls to control energy transfer from the external energytransfer unit to the implantable medical device.

In a preferred embodiment, the two operative controls comprise a startcontrol and a stop control.

In a preferred embodiment, the start control is a start button andwherein the stop control is a stop button.

In a preferred embodiment, the energy transfer unit also has operativecontrols to start and stop the therapeutic output of the implantablemedical device.

In a preferred embodiment, the energy transfer unit also has a controlto enable and silence audio feedback from the energy transfer unit.

In a preferred embodiment, the external energy transfer unit inductivelycouples energy to the implantable medical device.

In a preferred embodiment, the implantable medical device has arechargeable energy storage device and wherein the energy transfer unitcharges the rechargeable energy storage device.

In another embodiment, the present invention provides an implantablemedical device system. An implantable medical device provides atherapeutic output to a patient. The implantable medical device iscapable of receiving inductively coupled energy with a secondary coiland is capable of being transcutaneously controlled using an internaltelemetry coil. An external antenna has a primary coil adapted toinductively transfer energy to the secondary coil of the implantablemedical device when the external antenna is externally placed inproximity of the secondary coil. An external energy transfer unit isadapted to be operatively coupled by a cord to the external antennadriving the primary coil to inductively transfer energy to theimplantable medical device. The energy transfer unit has an externaltelemetry coil allowing the energy transfer unit to communicate with theimplantable medical device through the internal telemetry coil in orderto at least partially control the therapeutic output of the implantablemedical device.

In another embodiment, the present invention provides an external energytransfer system adapted to transcutaneously transfer energy to animplantable medical device for providing a therapeutic output to apatient. The implantable medical device is capable of receivinginductively coupled energy with a secondary coil and is capable of beingtranscutaneously controlled using an internal telemetry coil. Anexternal antenna has a primary coil adapted to inductively transferenergy to the secondary coil of the implantable medical device when theexternal antenna is externally placed in proximity of the secondarycoil. An external energy transfer unit is adapted to be operativelycoupled by a cord to the external antenna driving the primary coil toinductively transfer energy to the implantable medical device. Theenergy transfer unit has an external telemetry coil allowing the energytransfer unit to communicate with the implantable medical device throughthe internal telemetry coil in order to at least partially control thetherapeutic output of the implantable medical device.

In another embodiment, the present invention provides a method ofcontrolling an implantable medical device for providing a therapeuticoutput. The implantable medical device is capable of receivinginductively coupled energy with a secondary coil and is capable of beingtranscutaneously controlled using an internal telemetry coil. Energy isinductively transferred to the secondary coil with an external antennahaving a primary coil when the external antenna is externally placed inproximity of the secondary coil. The primary coil is driven with anexternal energy transfer unit operatively coupled by a cord to theexternal antenna to inductively transfer energy to the implantablemedical device. An external telemetry coil in the energy transfer unitcommunicates with the implantable medical device through the internaltelemetry coil in order to at least partially control the therapeuticoutput of the implantable medical device.

In a preferred embodiment, the inductively transferring step and thecommunicating step occur simultaneously.

In a preferred embodiment, the energy transfer unit can control theimplantable medical device to turn the therapeutic output on and off.

In a preferred embodiment, the energy transfer unit can control theimplantable medical device using the external telemetry coil whiletransferring energy to the implantable medical using the primary coil ofthe antenna.

In a preferred embodiment, the implantable medical device has arechargeable energy storage device and wherein the energy transfer unitcharges the rechargeable energy storage device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of an external programmer and an externalcharging device for an implantable medical device such as can beutilized in the present invention;

FIG. 2 is a detailed block diagram of an implantable medical deviceimplanted subcutaneously and an associated external charging device inaccordance with an embodiment of the present invention;

FIG. 3 illustrates the start-up flow of an external programmer usable inconjunction with an implantable medical device;

FIG. 4 illustrates operation flow of an external programmer usable inconjunction with an implantable medical device;

FIG. 5 illustrates a therapy status screen of an external programmer;

FIG. 6 illustrates access to menu selection of an external programmer;

FIG. 7 illustrate group selections of an external programmer;

FIG. 8 illustrate parameter selections of an external programmer;

FIG. 9A illustrate screens of an external programmer;

FIG. 9B illustrate messages of an external programmer;

FIG. 9C illustrate warnings of an external programmer;

FIG. 10 illustrate menu selections of an external programmer;

FIG. 11 illustrates audio status of an external programmer;

FIG. 12 illustrates contrast of an external programmer;

FIG. 13 illustrates INS/ENS time of an external programmer;

FIG. 14 illustrate time/number formats of an external programmer;

FIG. 15 illustrate patient programmer information;

FIG. 16 illustrates INS/ENS information;

FIG. 16A illustrates Telemetry N information;

FIG. 17 illustrates the navigation flow of an external charger forrecharging the INS;

FIG. 18 illustrates the navigation flow of an external charger forrecharging the external power source;

FIG. 19 illustrates screen shots of charge status of an externalcharger;

FIG. 20 illustrates status messages displayed during charging of theINS;

FIG. 21 illustrates external power source charge status screens;

FIG. 22 illustrates status messages displayed during recharging of theexternal power source; and

FIGS. 23A and 23B illustrate screens, information messages and warnings.

FIG. 24 shows a table of user interface components.

FIGS. 25-30 show tables of external programming unit user interfaceicons.

FIGS. 31-36 show tables of external charging unit user interface icons.

FIG. 37 shows a table of keypad buttons.

DETAILED DESCRIPTION OF THE INVENTION

In FIG. 1, external programming unit 2 is attachable via cord 4 to anexternal telemetry coil 6. External programming unit 2 can programoperations implantable medical device 16 (FIG. 2) in a conventionalmanner using external telemetry coil 6. External antenna 52 isattachable via cord 56 to external charging device 48 is inductivelytransfer power to implantable medical device 16 when external antenna 52is placed in proximity of a secondary coil 24 associated withimplantable medical device 16. External charging device 48 receives ACpower from cord 8 through transformer 10. External antenna 52 can beheld in position on a patient with belt 12.

FIG. 2 illustrates an embodiment of implantable medical device 16situated under cutaneous boundary 38. Charging regulation and therapycontrol is conventional. Implantable medical device 16 also has internaltelemetry coil 44 configured in conventional manner to communicatethrough external telemetry coil 46 to an external programming device 2,charging unit 50 or other device in a conventional manner in order toboth program and control implantable medical device and to externallyobtain information from implantable medical device 16 once implantablemedical device has been implanted. Internal telemetry coil 44,rectangular in shape with dimensions of 1.85 inches (4.7 centimeters) by1.89 inches (4.8 centimeters) constructed from 150 turns of 43 AWG wire,is sized to be larger than the diameter of secondary charging coil 34.Secondary coil 34 is constructed with 182 turns of 30 AWG wire with aninside diameter of 0.72 inches (1.83 centimeters) and an outsidediameter of 1.43 inches (3.63 centimeters) with a height of 0.075 inches(0.19 centimeters). Magnetic shield 36 is positioned between secondarycharging coil 34 and housing 32 and sized to cover the footprint ofsecondary charging coil 34.

Internal telemetry coil 44, having a larger diameter than secondary coil34, is not completely covered by magnetic shield 36 allowing implantablemedical device 16 to communicate with the external programming devicewith internal telemetry coil 44 in spite of the presence of magneticshield 36.

Rechargeable power source 24 can be charged while implantable medicaldevice 16 is in place in a patient through the use of external chargingdevice 48. In a preferred embodiment, external charging device 48consists of charging unit 50 and external antenna 52. Charging unit 50contains the electronics necessary to drive primary coil 54 with anoscillating current in order to induce current in secondary coil 34 whenprimary coil 54 is placed in the proximity of secondary coil 34.Charging unit 50 is operatively coupled to primary coil by cable 56. Inan alternative embodiment, charging unit 50 and antenna 52 may becombined into a single unit. Antenna 52 also contains external telemetrycoil 46 which may be operatively coupled to charging unit 50 if it isdesired to communicate to or from implantable medical device 16 withexternal charging device 48. Alternatively, antenna 52 may containexternal telemetry coil 46 which can be operatively coupled to externalprogramming device 2, either individually or together with externalcharging unit 48.

The user interface of external programming unit 2 is illustrated byreference to FIG. 3 through FIG. 16. The following terms are usedthroughout the description of the user interface of external programmingunit 2.

As noted below in the explanation of acronyms utilized in the followingparagraphs and table, DTC refers to desktop charger which is used todenote the AC power supply (transformer 10) and power cord (cord 8). TheDTC is “docked” when external charger 48 is connected to an source of ACpower. The DTC is “undocked” when external charger 48 is disconnectedfrom a source of AC power.

-   -   DTC Desktop Charger    -   ENS External Neurostimulator    -   INS Implanted Neurostimulator    -   INSR Another name for the RX1 Patient Recharger. Acronym stands        for Implanted Neurostimulator Recharger    -   LCD Liquid Crystal Display

Refer to FIG. 3 and FIG. 4 for start-up flow and navigation flow,respectively.

User interface components in the keypad are shown in FIG. 24.

The LCD is backlit and consists of 96 (Horizontal)×58 (Vertical) dotswith asymmetrical dots 0.35 (H)×0.4 (V). The active area on the LCD is33.3 mm (H)×23.2 mm (V). Four colors of display available. These arenamed below (from lightest to darkest):

-   -   White    -   Light Gray    -   Dark Gray    -   Black

Icons are shown in Tables 1-6 shown in FIGS. 25-30.

-   -   Notes:        -   Coordinates specified in the Tables 1-6 below are based on            rows numbered 0-57 and columns numbered 0-95        -   Effective display area: rows 1-56, columns 1-94; always            leave rows 0 and 57, columns 0 and 95 blank        -   With the exception of status_stim_on, status_stim_off and            status_ins_battery_* in Table 1, check_off in Table 2,            specified size in Tables 1-6 includes a 1-pixel wide white            border around all symbols    -   Notes        -   a) Column position will vary, depending on parameter value        -   b) All numbers will be displayed in R37; column position            will vary, depending on parameter symbol and value    -   Note: display msg_wait_signal and msg_ir_communication for IR        Communication Screen    -   Note: display Text for Splash (Med 15 pt font) and Wait        Signal—Splash (msg_wait_signal) for Splash Screen    -   *Note: column position will vary, depending on codes displayed    -   Notes        -   1) Displayed on all menu selection screens        -   2) Row position will vary, depending on menu box that is            displayed: R10 for menu_box_26×78; R34 for menu_box_16×78;            R35 for menu_box_16×21 and menu_box_16×13; R40 for            menu_box_27×78    -   3) C2 for hours; C27 for minutes    -   4) Column position will vary, depending on contrast setting    -   5) Column position will vary, depending on values    -   6) Display “PT” next to menu_info for Patient Programmer        Information, “NSI” next to menu_info for INS/ENS Information and        “TNT” next to menu_info for Telemetry N Information    -   7) Med 15 pt font will be used for Patient Programmer        Information and INS/ENS Information.

Therapy status screen display layout is divided vertically into threelines of information: status line, groups line and parameters line asshown in FIG. 5. When a successful initial interrogation has beenperformed, software will display the Therapy Status Screen of the activeset with the following highlighting priority: parameters line ifdisplayed; groups line if displayed; and status line.

Scroll up and scroll down keys will be used to access the status line,groups line and parameters line on the display. A box highlights userselection. Scroll left and right will be used to cycle through availablechoices for a selected line. Software will display a “real-time” INScharge level on the status line. The charge level will be updated anddisplayed whenever a parameter adjustment is made. Software will displayprogrammer battery status on the status line.

Access to Menu Selections is from the status line are shown in FIG. 6.Initial interrogation will include data on all groups currentlyavailable to the patient (“Baseline” setting).

Software will display labels for all groups the user can activate,including those containing no adjustable parameters. Refer to FIG. 7 forGroup Selections. All unnecessary text will be removed from the display:e.g., if there is only 1 group, software will not display the groupsline. Software will not display parameters that the user cannot adjust:i.e., the clinician programmer disallows access or upper and lowerlimits are the same. The user will access all available groups byscrolling through a linear list: A, B, C, . . . , Z. When the userscrolls to a different group, software will display the first adjustableparameter in the group. The user will scroll left/right throughavailable groups to access an inactive group.

Software will display all adjustable parameters for inactive groups. Theuser will scroll down to highlight parameters and scroll left or rightto view them. If a user presses Therapy Off or Therapy On when thescreen displays an inactive group, software will turn the INS off, anddisplay the Therapy Status Screen with the active group highlighted. Acheck in its check box will be used to indicate an active group(check_on); a check box without a check will be used to indicateinactive groups (check_off). The user will press the Sync key toactivate a group at the displayed parameter value(s).

The neurostimulator does not have to be on to activate a new group. Theuser can activate a group when therapy is off. The user can activate anew group when the groups line is highlighted or when the parametersline is highlighted. The check box will be updated whenever a new groupis activated.

Software will display labels for all parameters the user can adjust asshown in FIG. 8, Parameter Selections. Software will display the firstadjustable parameter of the active group when a Sync has been performedfor an initial interrogation. The user will access all adjustableparameters by scrolling through a linear list. The order of scrollingthrough adjustable parameters in a group is Amp1, Amp2, Amp3, Amp4, PW1,PW2, PW3, PW4, Rate, Amp1, . . . Refer to FIG. 8, Parameter Selections.Increase/decrease keys will be inactive until a session has beeninitiated—i.e., the INS has been interrogated. When the user presses andholds the increase/decrease keys, software will send a change to theneurostimulator every ½ second. When the user changes a parameter,software will display the updated parameter value.

Therapy control events are described in screens, information messagesand warnings that are displayed on the programmer as shown in FIGS. 9A,9B and 9C. Operational requirements are described in tables that specifyconditions for entry and expected changes in control.

-   -   Power Down Screen (blank display)        -   Screen Entry: User Control/System Event            -   System timeout or Power Button keypress

User Control/System Event System Response: Table 10 reference Powerbutton Start Screen, 14, 15 Therapy On 1, 2, 3, 5, 6, 7, 8, 9, 11, 12,13, 14, 15, 20, 23, 24 Therapy Off 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13,14, 15, 20, 23, 24 Sync 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20,23, 24 Scroll up/down/ Ignore Scroll left/right Increase/Decrease IgnoreReplace programmer Splash Screen batteries

-   -   Start Screen        -   Screen Entry: User Control/System Event            -   Power button

User Control/System Event System Response: Table 10 reference Therapy On1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Therapy Off 1, 2,3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Sync 1, 2, 3, 5, 6, 7,8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Power button/System Power DownScreen timeout Scroll up/down/Scroll Ignore left/right Increase/DecreaseIgnore Increase + Decrease and 10 hold for 2-3 seconds

-   -   Therapy Status Screen        -   Screen Entry: User Control/System Event            -   Telemetry success

User Control/ System Event System Response: Table 10 reference TherapyOn 1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Therapy Off1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Sync 1, 2, 3,4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Increase 1, 2, 3, 4, 5,6, 7, 8, 9, 11, 12, 13, 14, 15, 17, 20, 23, 24 Decrease 1, 2, 3, 4, 5,6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 19, 20, 23, 24 Scroll left/rightAudio Screen, Time/Number Formats from status line Power button/SystemPower Down Screen timeout

The i symbol will be displayed on all information messages as shown inFIG. 9B. The user can clear all messages by pressing the 4-way button(Scroll up/down, Scroll left/right), Therapy Off to turn stimulation offor the Power button to turn the display off. If the system times out,the display will turn off (Power Down Screen). Refer to Table 7.

TABLE 1 Processing Requirements for Information Messages Message UserControl/System Response: Feedback/Next Screen INS Battery Low 4-waybutton: Therapy Status Stim Off: Table 10-1, 2, 3, 6, 11, 12, 13, 14,15, 23, 24 Stim On: ignore Sync: ignore Increase/Decrease: ignore Systemtimeout or Power button: Power Down ENS Battery Low 4-way button:Therapy Status Stim Off: Table 10-1, 2, 3, 8, 9, 12, 13, 14, 15, 20, 23,24 Stim On: ignore Sync: ignore Increase/Decrease: ignore System timeoutor Power button: Power Down Programmer Battery 4-way button: Previousscreen Low Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 15,20, 23, 24 Stim On: ignore Sync: ignore Increase/Decrease: ignore Systemtimeout or Power button: Power Down Amp at Upper Limit 4-way button:Therapy Status Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13,14, 15, 20, 23, 24 Stim On: ignore Sync: ignore Increase/Decrease:ignore System timeout or Power button: Power Down PW at Upper Limit4-way button: Therapy Status Stim Off: Table 10-1,2, 3, 5, 6, 7, 8, 9,11, 12, 13, 14, 15, 20, 23, 24 Stim On: ignore Sync: ignoreIncrease/Decrease: ignore System timeout or Power button: Power DownRate at Upper Limit 4-way button: Therapy Status Stim Off: Table 10-1,2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14,15, 20, 23, 24 Stim On: ignore Sync:ignore Increase/Decrease: ignore System timeout or Power button: PowerDown Amp at Lower Limit 4-way button: Therapy Status Stim Off: Table10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Stim On:ignore Sync: ignore Increase/Decrease: ignore System timeout or Powerbutton: Power Down PW at Lower Limit 4-way button: Therapy Status StimOff: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24Stim On: ignore Sync: ignore Increase/Decrease: ignore System timeout orPower button: Power Down Rate at Lower Limit 4-way button: TherapyStatus Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15,20, 23, 24 Stim On: ignore Sync: ignore Increase/Decrease: ignore Systemtimeout or Power button: Power Down Poor Communication- Allow a repeatof the last keypress for Stim On, Sync, Increase and INS Decrease 4-waybutton: Sync Up Required Stim Off: Table 10-1, 2, 3, 5, 6, 11, 12, 13,14, 15 Stim On: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15 Sync: Table10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15 Increase/Decrease: Table 10-1, 2,3, 5, 6, 11, 12, 13, 14, 15, 16, 17, 18, 19 System timeout or Powerbutton: Power Down Poor Communication- Allow a repeat of the lastkeypress for Stim On, Sync, Increase and ENS Decrease 4-way button: SyncUp Required Stim Off: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24Stim On: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24 Sync: Table10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24 Increase/Decrease: Table 10-2,7, 8, 9, 12, 13, 14, 15, 16, 17, 18, 19, 20, 23, 24 System timeout orPower button: Power Down Sync Up 4-way button: Therapy Status Stim Off:Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Stim On:Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24 Sync:Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20Increase/Decrease: ignore System timeout or Power button: Power DownTurn Stimulation On 4-way button: Therapy Status Stim Off: ignore StimOn: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24Sync: ignore Increase/Decrease: ignore System timeout or Power button:Power Down Connect ENS Cable 4-way button: Sync Up Required Stim Off:Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24 Stim On: Table 10-2, 7,8, 9, 12, 13, 14, 15, 20, 23, 24 Sync: ignore Increase/Decrease: ignoreSystem timeout or Power button: Power Down

The exclamation mark symbol will be displayed on all warnings as shownin FIG. 9C. All warnings will remain on the display until the user takesappropriate action. Refer to Table 8.

TABLE 2 Processing Requirements for Warning Messages User Action/SystemResponse: Message Feedback/Next Screen Recharge Stimulator Systemtimeout or Power button: Power Down Replace ENS Battery System timeoutor Power button: Power Down Replace Programmer Replace programmerbattery: Start Screen Battery System timeout or Power button: Power DownSync Up Required Sync button or Therapy On or Therapy Off: TherapyStatus System timeout or Power button: Power Down Call Your DoctorTherapy Off and telemetry success with audio feedback: Call Your DoctorTherapy Off and telemetry failure with audio feedback: Call Your DoctorSystem timeout or Power button: Power Down Call Your Doctor-EOS Systemtimeout or Power button: Power Down Call Your Doctor-POR System timeoutor Power button: Power Down

“In the box” messages are described in Table 9.

-   -   “In the Box” Messages        -   Software will notify the user with 3 beeps when “In the Box”            messages are displayed        -   All “In the Box” messages will remain on the display until            the system times out or the user presses the Power button to            turn off the display. Refer to Table 9.

TABLE 3 Processing Requirements for “In the Box” Messages UserAction/System Response: Feedback/Next Message Screen INS in the BoxSystem timeout or Power button: Power Down ENS in the Box System timeoutor Power button: Power Down

Therapy control events are described in Table 10.

TABLE 4 Processing Requirements for Therapy Control Events and DeviceCommunication User Control/System Event System Response 1. Communicatingwith the INS Display Communicating-INS Message 2. Successful telemetryDisplay Therapy Status Screen 3. Telemetry failure-INS Display PoorCommunication-Th4S Message 4. Software is unable to refresh/update theDisplay Sync Up Required Warning Therapy Status Screen after a telemetryfailure 5. INS battery low Display INS Battery Low Message 6. INSbattery depleted Display Recharge Stimulator Warning 7. ENS battery lowor battery Display ENS Battery Low Message disconnected 8. ENS batterydepleted Display Replace ENS Battery Warning 9. ENS screening cabledisconnected Display Connect ENS Cable Message 10. User pressesIncrease + Decrease and Display Patient Information Screen holds for 2-3seconds 11. INS error-EOS Display Call Your Doctor-EOS Warning 12. INSerror-battery voltage too high; Display Call Your Doctor Warning /ENSerror-POR, battery voltage too high 13. System Error and Warning DisplayCall Your Doctor Warning 14. Patient programmer battery low DisplayProgrammer Battery Low Message 15. Patient programmer battery depletedDisplay Replace Programmer Battery Warning 16. Parameter at lower limitDisplay At Lower Limit Message 17. Parameter at upper limit or out ofreg Display At Upper Limit Message 18. Increase with therapy off DisplayTurn Stimulation On Message 19. Increase/decrease parameter of inactiveDisplay Sync Up Message group 20. ENS error-POR, battery voltage tooDisplay Communicating-ENS, low followed by INS/ENS Time with 12:00displayed 21. Communicating via IR Display IR Communication Screen 22.Replace programmer batteries Display Splash Screen 23. Communicatingwith the ENS Display Communicating-ENS Message 24. Telemetry failure-ENSDisplay Poor Communication-ENS Message 25. INS error-locked normalDisplay INS in the Box Message 26. ENS error-ENS has no programs orDisplay ENS in the Box Message groups 27. INS error-POR Display CallYour Doctor-POR Warning

Access to menu selections is from the status line on the Therapy Screenas shown in FIG. 10.

The display is divided vertically into two lines of information: menuoption line and value line. Scroll up and down keys will be used toaccess the menu option line and the value line on the display. A boxhighlights user selection. Scroll right and left and increase/decreasekeys will be used to change values for Audio, Contrast, Time/NumberFormat and the Information options. In addition, Increase/decrease keyswill be used to change values.

Software will display screens for the menu options in Table 11 MenuSelections.

TABLE 5 Menu Selections and Navigation Flow Menu Item References AudioFIG. 11, Table 12-1, Contrast FIG. 12, Table 12-1, 4, 6, 9 INS/ENS TimeFIG. 13, Table 12-1, 2, 4, 7, 8, 9 Time/Number Format FIG. 14, Table12-1, 3, 9 Patient Programmer Information FIG. 15, Table 12-1, 2, 9, 10INS/ENS Information FIG. 16, Table 12-1, 2, 9, 10 Telemetry NInformation FIG. 16A, Table 12-1, 2, 9, 10

The user interface of the external charger is described below. Adescription of the user interface for an external recharger for animplantable medical device is described. The appearance of the screensand how users interact with these screens are defined.

The following terms are used throughout the description of the userinterface for the external charger.

-   -   DTC Desktop Charger    -   ENS External Neurostimulator    -   INS Implanted Neurostimulator    -   INSR Another name for the RX1 Patient Recharger. Acronym stands        for Implanted Neurostimulator Recharger    -   LCD Liquid Crystal Display

Refer to FIG. 17 and FIG. 18 for navigation flow.

FIG. 17 illustrates a process for charging rechargeable power source 24in implantable medical device 16 by using external charging device 48.

In order to charge rechargeable power source 24, a patient may use belt12 to attach external antenna 52 to the patient's body at approximatelythe location of implanted medical device 16. It is desirable thatprimary coil 54 of external antenna 52 be aligned as closely as possiblewith secondary coil 34 of implantable medical device 16. Techniques forattaching external antenna 52 to the patient's body and positioningprimary coil 54 in close proximity to secondary coil 34 can be found inco-pending U.S. patent application Ser. No. 10/837,506, filed Apr. 30,2004, the entire contents of which are hereby incorporated by reference.This application claims priority from U.S. Provisional PatentApplication Ser. No. 60/508,174, filed Oct. 2, 2003.

After affixing external antenna 52 to the approximate location ofimplantable medical device 16, the patient (or other user such as amedical professional or family member assisting the patient) may thenpress (step 110) the “Start Charge” button 90 (FIG. 1) on charging unit50.

Charging unit 50 then determines (step 112) if telemetry withimplantable medical device 16 is successful. If telemetry isunsuccessful (step 114), an error message is generated such as atelemetry timeout (Reposition Antenna—Press Start Charge), system error(Antenna Too Hot) or external charging device 48 error due to INSRbattery low or INSR battery depleted and external charging devicedisplays the appropriate message. If telemetry is successful, thencharging unit 50 waits (step 116) and the appropriate charge status maybe indicated (step 118) in the display of charging unit 50.

If charging of rechargeable power source 24 is not yet complete (step120), charging unit 50 returns through step 118. The surface temperatureof antenna 52 is monitored as well as the charging current and batteryvoltage levels. An error message is generated and charging is suspendedif measurements are not within limits.

Once charging of rechargeable power 24 is complete (step 122), chargingunit 50 indicates in the display that charging is complete and the usermay press the “Stop Charge” button 92 on charging unit 50 to terminatethe charging process. Of course, it is to recognized and understood thatthe “Stop Charge” button 92 may be pressed at any time during thecharging process in order to terminate the charging process, i.e., theuser need not wait until the complete charging has been indicated.

Charging unit 50 may be operated to charge rechargeable power 24 inimplantable medical device 16 by the use of only two buttons, namely the“Start Charge” button 90 and the “Stop Charge” button 92. These are theonly two buttons which need be used. While a preferred embodiment ofcharging unit 50 does contain a third button, namely “Silence” button94, this third button is not necessary. “Silence” button 94 is used onlyto disable, or to re-enable, audio output of charging unit 50. Sinceaudio feedback is not required for the charging process, this button maybe used or not at the convenience of the user.

In an alternative embodiment, charging unit 50 may itself be powered bya rechargeable power source, such as a battery. Since the chargingprocess could take several hours, it would be desirable.

FIG. 18 illustrates the process used to charge the external chargingunit 48. The external charging unit 48 is connected (step 124) to asuitable power source, such as a readily available AC power outlet. Acheck is made (step 126) to determine whether a “recharge event”, i.e.,an alert or alarm condition, has occurred and, if so, issue theappropriate message (step 128). If a “recharge event” has not occurred,the process updates and displays (step 130) the charge status ofexternal charging device 48. If recharge of external charging is notcomplete (step 132), the process again updates and displays the chargingstatus in step 130. Once charging of external charging device 48 iscomplete (step 134), charging unit 50 displays a message indicative of acomplete charging process.

The LCD is backlit and consists of 96 (Horizontal)×58 (Vertical) dotswith asymmetrical dots 0.35 (H)×0.4 (V). The active area on the LCD is23.2 mm (V)×33.3 mm (H).

Four colors of display are available. These are named below (fromlightest to darkest):

-   -   White    -   Light Gray    -   Dark Gray    -   Black

The keypad has the following buttons shown in FIG. 37.

See Tables 12 through 17 as shown in FIGS. 31-36 for icons.

-   -   Note 1: display INS battery status symbol for current charge        level: ins_charge_25, ins_charge_50, ins_charge_75 (refer to        Table 12), or msg_ins_charge_complete (refer to Table 15)    -   Note 2: display INSR battery status symbol for current charge        level: insr_charge_25, insr_charge_50, insr_charge_75 (refer to        Table 14)    -   Note 3: display msg_insr_wait_signal (refer to Table 11) and        msg_ir_communication (refer to Table 5) for IR Communication        Screen    -   Note 4: display Text for Splash (Med 15 pt font) and Wait        Signal—Splash (msg_wait_signal) for Splash Screen

The INS charge status screen display is divided vertically into threelines of information: status line, recharge progress line and rechargeefficiency line. Refer to FIG. 19 and FIG. 20.

Therapy On, Therapy Off, Start Charge and Stop Charge are dedicatedfunction keys. When the display is blank and the user presses TherapyOn, Therapy Off or Start Charge, software will perform the function andturn the display on. System timeout is <30 seconds.

The INS battery status display has 5 settings: 0%, 25%, 50%, 75% and100%. During recharge, software will display the appropriate quartilesin solid fill and the next higher quartile in a flashing on/off mannerevery second. The exception is 100%. Even if the INS battery voltageindicates 100%, software will flash the last quartile until the rechargesession is complete.

The INSR charge status screen display is divided vertically into twolines of information: status line and recharge progress line. Refer toFIG. 21, INSR Charge Status Screen, and FIG. 22, Recharging the INSR.

The INSR battery status has 5 settings: 0%, 25%, 50%, 75% and 100%.During recharge, software will display the appropriate quartiles insolid fill and the next higher quartile in a flashing on/off mannerevery second. The exception is 100%. Even if the INSR battery voltageindicates 100%, software will flash the last quartile until the rechargesession is complete.

Recharging events are described in screens, information messages andwarnings that are displayed on the recharger as shown in FIG. 23A andFIG. 23B. Operational requirements are described in tables that specifyconditions for entry and expected changes in control. Refer to theoperational requirements for each screen in this section.

The i symbol will be displayed on all information messages. With theexception of INSR System Information screen, the user can exit themessages by pressing Audio or wait for the system to timeout. Therapy Onand Off will always be active when the messages are displayed. When theuser presses Therapy On or Off, software will turn stimulation on/offand clear the information message.

The exclamation mark symbol will be displayed on all warnings. Allwarnings will remain on the display until the user takes appropriateaction.

-   -   1—Power Down Screen (blank display)    -   Screen Entry: User Control/System Event        -   System timeout from Start Screen—Not Docked

User Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Start Screen-Not Dockedwith Therapy On/Off icon on status line (Table 17-22) Telemetry event:refer to Table 18 Start Charge Antenna temperature OK: Wait Screen(Table 17-1) Antenna too hot: Antenna Too Hot Message (Table 17-30)Antenna failure: Call Your Doctor Warning (Table 17-18) Antennadisconnected: Connect INSR Antenna Message (Table 17-14) INSR batterylow: INSR Battery Low Message (Table 17-8) INSR battery depleted:Recharge INSR Warning (Table 17-9) Stop Charge No change Audio StartScreen-Not Docked (Table 17-24, 25) INSR battery low: INSR Battery LowMessage (Table 17-8) INSR battery depleted: Recharge INSR Warning (Table17-9) Attach DTC INSR recharge complete: INSR Recharge Complete Message(Table 17-11) INSR recharge incomplete: INSR Charge Status Screen (Table17-7) Audio + Stop Charge INSR System Information Message (Table 17-17)Audio + Start Charge Antenna temperature OK: Physician Recharge Screen(Table 17- and hold for > 10 21) seconds Antenna too hot: PhysicianRecharge-Antenna Too Hot (Table 17-31)

-   -   2—Start Screen—Not Docked    -   Screen Entry: User Control/System Event        -   Therapy On/Off keys when the recharger is powered down        -   Audio key when the recharger is powered down        -   Any key from Splash Screen        -   Detach DTC        -   System timeout or message clear when DTC is detached        -   Stop Charge from Physician Recharge Screen or Physician            Recharge—Antenna Too Hot Screen        -   Host terminates the session, the Reset button is activated            or the user presses Audio from IR Communication Screen

User Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Therapy On/Off icon onstatus line (Table 17-22) Telemetry event: refer to Table 18 StartCharge Antenna temperature OK: Wait Screen (Table 17-1) Antenna too hot:Antenna Too Hot Message (Table 17-30) Antenna failure: Call Your DoctorWarning (Table 17-18) Antenna disconnected: Connect INSR Antenna Message(Table 17-14) INSR battery low: INSR Battery Low Message (Table 17-8)INSR battery depleted: Recharge INSR Warning (Table 17-9) Stop Charge Nochange Audio Audio icon (Table 17-24) INSR battery low INSR Battery LowMessage (Table 17-8) INSR battery depleted Recharge INSR Warning (Table17-9) System error Call Your Doctor Warning (Table 17-18) Attach DTCINSR recharge complete: INSR Recharge Complete Message (Table 17-11)User Control / System Response: Feedback/Next Screen (requirement)System Event INSR recharge incomplete: INSR Charge Status Screen (Table17-7) Audio + Stop Charge INSR System Information Message (Table 17-17)Audio + Start Charge Antenna temperature OK: Physician Recharge Screen(Table and hold for > 10 17-21) seconds Antenna too hot: PhysicianRecharge-Antenna Too Hot (Table 17-31) System timeout Power Down Screen

-   -   3—Start Screen—Docked    -   Screen Entry: User Control/System Event        -   System timeout or message clear        -   Any key from Splash Screen        -   Host terminates the session, the Reset button is activated            or the user presses Audio from the Splash Screen        -   Stop Charge from Physician Recharge Screen or Physician            Recharge—Antenna Too Hot Screen

User Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Therapy On/Off icon onstatus line (Table 17-22) Telemetry event: refer to Table 18 StartCharge Antenna temperature OK: Wait Screen (Table 17-1) Antenna too hot:Antenna Too Hot Message (Table 17-30) Antenna failure: Call Your DoctorWarning (Table 17-18) Antenna disconnected: Connect INSR Antenna (Table17-14) Stop Charge No change Audio Audio icon (Table 17-24) System errorCall Your Doctor Warning (Table 17-18) Detach DTC Start Screen-NotDocked Audio + Stop Charge INSR System Information Message (Table 17-17)Audio + Start Charge Antenna temperature OK: Physician Recharge Screen(Table and hold for > 10 17-21) seconds Antenna too hot: PhysicianRecharge-Antenna Too Hot (Table 17-31)

-   -   4—Wait Screen    -   Screen Entry: User Control/System Event        -   Start Charge        -   Antenna temperature OK        -   System timeout or message clear

User Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off No change Telemetry success INS ChargeStatus Screen or INS Charge Status-90 to 100% Screen (Table 17-2)Telemetry failure or- Reposition Antenna-Press Start Charge Warning(Table 17-12) poor charging condition INS error: ERI Call YourDoctor-ERI Message Table 17-19) INS error: POR Call Your Doctor-PORMessage (Table 17-27) INS error: EOS, battery- Call Your Doctor Warning(Table 17-18) voltage too high INSR battery low INSR Battery Low Message(Table 17-8) INSR battery depleted Recharge INSR Warning (Table 17-9)Antenna too hot INS Charge Status-Antenna Too Hot (Table 17-13) Antennafailure Call Your Doctor Warning (Table 17-18) Antenna disconnectedConnect INSR Antenna Message (Table 17-14) System error Call Your DoctorWarning (Table 17-18) Start Charge No change Stop Charge (not- StartScreen-Not Docked docked) Stop Charge (docked) INSR recharge incomplete:INSR Charge Status Screen (Table 17-7) INSR recharge complete: INSRRecharge Complete Message (Table 17-11) Audio No change Attach DTC Nochange Detach DTC No change Audio + Stop Charge No change Audio + StartCharge No change and hold for > 10 seconds

-   -   5—INS Charge Status Screen    -   Screen Entry: User Control/System Event        -   Telemetry success        -   System timeout or message clear        -   Antenna temperature OK

User Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Therapy On/Off icon onstatus line (Table 17-22) Telemetry event: refer to Table 18 StartCharge Antenna temperature OK: refresh recharge efficiency line (Table17-26) Antenna too hot: INS Charge Status-Antenna Too Hot (Table 17-13)Stop Charge Charge complete: INS Recharge Complete Message (Table 17- 6)Charge incomplete and not INS battery low: INS Recharge InterruptedMessage (Table 17-5) INS battery low: INS Battery Low Message (Table17-3) INS battery depleted: Recharge Stimulator Warning (Table 17- 4)Audio Toggle Audio icon (Table 17-24) Attach DTC Power source symbol onstatus line (Table 17-23) Detach DTC INSR battery low: INSR Battery LowMessage (Table 17-8) INSR battery depleted: Recharge INSR Warning (Table17-9) Status line without power source symbol (Table 17-23) INS rechargecomplete INS Recharge Complete Message (Table 17-6) INS error: ERI CallYour Doctor ERI Message (Table 17-19) INS error: POR Call YourDoctor-POR Message (Table 17-27) INS error: EOS, battery Call YourDoctor Warning (Table 17-18) voltage too high Antenna too hot INS ChargeStatus-Antenna Too Hot (Table 17-13) Antenna failure Call Your DoctorWarning (Table 17-18) Antenna disconnected Connect INSR Antenna Message(Table 17-14) INSR battery low INSR Battery Low Message (Table 17-8)INSR battery depleted Recharge INSR Warning (Table 17-9) INSR rechargeINSR Batt1 on status line (Table 17-25) complete System error Call YourDoctor Warning (Table 17-18) Audio +Stop Charge No change Audio + StartCharge No change and hold for > 10 seconds

-   -   6—INSR Charge Status Screen    -   Screen Entry: User Control/System Event        -   Attach DTC from Power Down Screen, Start Screen—Not Docked            or Recharge INSR Warning        -   Attach DTC from INSR Battery Low Message when not charging            INS        -   System timeout or message clear

User Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Therapy On/Off icon onstatus line (Table 17-22) Telemetry event: refer to Table 18 StartCharge Antenna temperature OK: Wait Screen (Table 17-1) Antenna too hot:Antenna Too Hot Message (Table 17-30) Audio Toggle Audio icon (Table17-24) Detach DTC Charge incomplete and not INSR battery low: INSRRecharge Interrupted Message (Table 17-10) INSR battery low: INSRBattery Low Message (Table 17-8) INSR battery depleted: Recharge INSRWarning (Table 17-9) INSR recharge complete: INSR Recharge CompleteMessage (Table 17-11) INSR recharge INSR Recharge Complete Message(Table 17-11) complete Audio + Start Charge Antenna temperature OK:Physician Recharge Screen (Table and hold for > 10 17-21) secondsAntenna too hot: Physician Recharge-Antenna Too Hot (Table 17-31) Systemerror Call Your Doctor Warning (Table 17-18)

-   -   7—Physician Recharge Screen    -   Screen Entry: User Control/System Event        -   Audio+Start Charge and hold for >10 seconds        -   Antenna temperature OK        -   System timeout or message clear

User Control/ System Response: Feedback/Next System Event* Screen(requirement) Successful INS Charge Status Screen (Table 17-2)communication with INS Timer goes to zero and Start Screen-Not Dockedsystem times out (not without Therapy On/Off icon on docked) status line(Table 17-22) Timer goes to zero and INSR recharge in complete: INSRsystem times out Charge Status Screen (Table 17-7) (docked) INSRrecharge complete: INSR Recharge Complete Message (Table 17-11) StopCharge (not Start Screen-Not Docked docked) Stop Charge (docked) StartScreen-Docked Detach DTC INSR battery low: INSR Battery Low Message(Table 17-8) INSR battery depleted: Recharge INSR Warning (Table 17-9)Antenna too hot Physician Recharge-Antenna Too Hot (Table 17-31) Antennafailure Call Your Doctor Warning (Table 17-18) Antenna disconnectedConnect INSR Antenna Message (Table 17-14) System error Call Your DoctorWarning (Table 17-18) INSR battery low INSR Battery Low Message (Table17-8) INSR battery depleted Recharge INSR Warning (Table 17-9) INSRrecharge No change complete *Note: all keys inactive except Stop Charge

-   -   8—IR Communication Screen    -   Screen Entry: User Control/System Event        -   Reset button from any screen when DTC is not docked and IR            command is received    -   Processing Requirements        -   All keys inactive        -   Software will display the screen until the host terminates            the session, the Reset button is activated or the Audio key            is pressed. (Table 17-28)        -   When the host terminates the session or the Reset button is            activated, software will display Start Screen—Not Docked.    -   9—INS Battery Low Message    -   Screen Entry: User Control/System Event        -   Therapy On/Off

Entry Screen User Control/System Event: Next Screen Power Down Audio keyor system timeout: Start Screen-Not Docked with Start Screen-Not TherapyOn/Off icon on status line (Table 17-22) Docked Therapy On/Off andtelemetry success: Start Screen-Not Docked with Therapy On/Off icon onstatus line (Table 17 22) Therapy On/Off and telemetry event: Refer toTable 18 Start Charge and antenna temperature OK: Wait Screen (Table17-1) Start Charge and antenna too hot: Antenna Too Hot Message (Table17-30) Stop Charge: no change Attach DTC: no change Start Screen-DockedAudio key or system timeout: Start Screen-Docked with Therapy On/Officon on status line (Table 17-22) Therapy On/Off and telemetry success:Start Screen-Docked with Therapy On/Off icon on status line (Table17-22) Therapy On/Off and telemetry event: Refer to Table 18 StartCharge and antenna temperature OK: Wait Screen (Table 17-1) Start Chargeand antenna too hot: Antenna Too Hot Message (Table 17-30) Stop Charge:no change Detach DTC: no change INSR Charge Status Audio key or systemtimeout: INSR Charge Status Screen with Therapy On/Off icon on statusline (Table 17-22) Therapy On/Off and telemetry success: INSR ChargeStatus with Therapy On/Off icon on status line (Table 17-22) TherapyOn/Off and telemetry event: Refer to Table 18 Start Charge and antennatemperature OK: Wait Screen/INS Charge Status (Table 17-1) Start Chargeand antenna too hot: Antenna Too Hot Message (Table 17-30) Stop Charge:no change Detach DTC: no change

-   -   INS Battery Low Message—continued    -   Screen Entry: User Control/System Event        -   Stop Charge

Entry Screen User Control/System Event: Next Screen INS Charge Audio keyor system timeout: Start Screen-Not Docked Status Therapy On/Off andtelemetry success: Start Screen-Not (not docked) Docked with TherapyOn/Off icon on status line (Table 17-22) Therapy On/Off and telemetryevent: Refer to Table 18 Start Charge and antenna temperature OK: WaitScreen (Table 17-1) Start Charge and antenna too hot: Antenna Too HotMessage (Table 17-30) Stop Charge: no change Attach DTC: no change INSAudio key and INSR recharge in complete: INSR Charge Charge Status withTherapy On/Off icon on Status status line (Table 17-22) (docked) Audiokey and INSR recharge complete: INSR Recharge Complete Message (Table17-11) Therapy On/Off and telemetry success and INSR recharge incomplete: INSR Charge Status with Therapy On/Off icon on status line(Table 17-22) Therapy On/Off and telemetry success and INSR rechargecomplete: Start Screen-Docked with Therapy On/Off icon on status line(Table 17-22) Therapy On/Off and telemetry event: Refer to Table 18Start Charge and antenna temperature OK: Wait Screen (Table 17-1) StartCharge and antenna too hot: Antenna Too Hot Message (Table 17-30) StopCharge: no change Detach DTC: no change

-   -   10—INS Recharge Interrupted Message    -   Screen Entry: User Control/System Event        -   Stop Charge

Entry Screen User Control/System Event: Next Screen INS Charge Audio keyor system timeout: Start Screen-Not Docked Status Therapy On/Off andtelemetry success: Start Screen-Not (not docked) Docked with TherapyOn/Off icon on status line (Table 17-22) Therapy On/Off and telemetryevent: Refer to Table 18 Start Charge and antenna temperature OK: WaitScreen (Table 17-1) Start Charge and antenna too hot: Antenna Too HotMessage (Table 17-30) Stop Charge: no change Attach DTC: no change INSCharge Audio key or system timeout and INSR recharge in Status complete:INSR Charge Status with Therapy On/Off (docked) icon on status line(Table 17-22) Audio key or system timeout and INSR recharge complete:INSR Recharge Complete Message (Table 17-11) Therapy On/Off andtelemetry success and INSR recharge in complete: INSR Charge Status withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry success and INSR recharge complete: Start Screen-Docked withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry event: Refer to Table 18 Start Charge and antenna temperatureOK: Wait Screen (Table 17-1) Start Charge and antenna too hot: AntennaToo Hot Message (Table 17-30) Stop Charge: no change Detach DTC: nochange

-   -   11—INS Recharge Complete Message    -   Screen Entry: User Control/System Event        -   Stop Charge        -   INS recharge complete

Entry Screen User Control/System Event: Next Screen INS Charge Audio keyor system timeout: Start Screen-Not Docked Status Therapy On/Off andtelemetry success: Start Screen-Not (not docked) Docked with TherapyOn/Off icon on status line INS Charge (Table 17-22) Status- TherapyOn/Off and telemetry event: Refer to Table 18 90 to 100% Start Chargeand antenna temperature OK: Wait (not Screen (Table 17-1) docked) StartCharge and antenna too hot: Antenna Too Hot Message (Table 17-30) StopCharge: no change Attach DTC: no change INS Charge Audio key or systemtimeout and INSR recharge Status in complete: INSR Charge Status(docked) Audio key or system timeout and INSR INS Charge rechargecomplete: INSR Recharge Complete Status- Message (Table 17-11) 90 to100% Therapy On/Off and telemetry success and INSR recharge (docked) incomplete: INSR Charge Status with Therapy On/Off icon on status line(Table 17-22) Therapy On/Off and telemetry success and INSR rechargecomplete: Start Screen-Docked with Therapy On/Off icon on status line(Table 17-22) Therapy On/Off and telemetry event: Refer to Table 18Start Charge and antenna temperature OK: Wait Screen (Table 17-1) StartCharge and antenna too hot: Antenna Too Hot Message (Table 17-30) StopCharge: no change Detach DTC: no change

-   -   12—INSR Battery Low Message    -   Screen Entry: User Control/System Event        -   Therapy On/Off

Entry Screen User Control/System Event: Next Screen Power Down Audio keyor system timeout: Start Screen-Not Docked Start Screen- with TherapyOn/Off icon on status line (Table 17-22) Not Therapy On/Off andtelemetry success: Start Screen-Not Docked Docked with Therapy On/Officon on status line (Table 17-22) Therapy On/Off and telemetry event:Refer to Table 18 Start Charge and antenna temperature OK: Wait Screen(Table 17-1) Start Charge and antenna too hot: Antenna Too Hot Message(Table 17-30) Stop Charge: no change Attach DTC: INSR Charge Status withTherapy On/Off icon on status line (Table 17-23) INS Charge Audio key orsystem timeout: previous screen with Status Therapy On/Off icon onstatus line (Table 17-22) INS Charge Therapy On/Off and telemetrysuccess: Wait Screen Status- Therapy On/Off and telemetry event: Referto Table 18 90 to 100% Start Charge and antenna temperature OK: WaitScreen (Table 17-1) Start Charge and antenna too hot: INS ChargeStatus-Antenna Too Hot Screen (Table 17-13) Stop Charge: StartScreen-Not Docked Attach DTC: previous screen with Therapy On/Off iconand Power Source Symbol on status line (Table 17-22, 23)

-   -   Screen Entry: User Control/System Event        -   Start Charge

Entry Screen User Control/System Event: Next Screen Power Down Audio keyor system timeout: Wait Screen/INS Start Screen- Charge Status/INSCharge Status-90 to 100% Not Therapy On/Off and telemetry success: WaitScreen/INS Docked Charge/INS Charge Status-90 to 100% Status withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry event: Refer to Table 18 Start Charge and antenna temperatureOK: Wait Screen (Table 17-1) Start Charge and antenna too hot: AntennaToo Hot Message (Table 17-30) Stop Charge: no change Attach DTC: WaitScreen/INS Charge Status/INS Charge Status-90 to 100%

-   -   INSR Battery Low Message—continued    -   Screen Entry: User Control/System Event        -   Audio

Entry Screen User Control/System Event: Next Screen Power Down Audio keyor system timeout: Start Screen-Not Docked Therapy On/Off and telemetrysuccess: Start Screen-Not Docked with Therapy On/Off icon on status line(Table 17-22) Therapy On/Off and telemetry event: Refer to Table 18Attach DTC: INSR Charge Status

-   -   Screen Entry: User Control/System Event        -   INSR battery low condition

Entry Screen User Control/System Event: Next Screen Wait Screen Audiokey or system timeout or Attach DTC: Wait Screen/INS Charge Status/INSCharge Status-90 to 100% Physician Recharge Audio key or system timeoutor Attach DTC: Physician Recharge Physician Recharge- Audio key orsystem timeout or Attach DTC: Antenna Too Hot Physician Recharge-AntennaToo Hot INS Charge Status Audio key or system timeout or Attach DTC: INSCharge Status INS Charge Status Audio key or system timeout or AttachDTC: 90 to 100% INS Charge Status-90 to 100% INS Charge Status- Audiokey or system timeout or Attach DTC: Antenna Too Hot INS ChargeStatus-Antenna Too Hot Start Screen-Not Audio key or system timeout:Start Screen-Not Docked Docked Attach DTC: INSR Charge Status

-   -   INSR Battery Low Message—continued    -   Screen Entry: User Control/System Event        -   Detach DTC

Entry Screen User Control/System Event: Next Screen INS Charge Audio keyor system timeout: previous screen Status Therapy On/Off and telemetrysuccess: INS Charge previous screen with Status- 90 to 100% INS ChargeTherapy On/Off icon on status line (Table 17-22) Status- Therapy On/Offand telemetry event: Refer to Table 18 Antenna Start Charge and antennatemperature OK: Too Hot Wait Screen (Table 17-1) Start Charge andantenna too hot: INS Charge Status-Antenna Too Hot Screen (Table 17-13)Stop Charge: Start Screen-Not Docked Attach DTC: previous screen withpower source symbol on status line (Table 17-23) INSR Charge Audio keyor system timeout: Start Screen-Not Docked Status Therapy On/Off andtelemetry success: Start Screen-Not Docked with Therapy On/Off icon onstatus line (Table 17-22) Therapy On/Off and telemetry event: Refer toTable 18 Start Charge and antenna temperature OK: Wait Screen (Table17-1) Start Charge and antenna too hot: Antenna Too Hot Message (Table17-30) Stop Charge: no change Attach DTC: INSR Charge Status PhysicianAudio key or system timeout: previous screen Recharge Therapy On/Off: nochange Screen Start Charge: no change Physician Stop Charge: StartScreen-Not Docked Recharge Attach DTC: previous screen Antenna Too Hot

-   -   13—INSR Recharge Interrupted Message    -   Screen Entry: User Control/System Event        -   Detach DTC

Entry Screen User Control/System Event: Next Screen INSR Charge Audiokey or system timeout: Start Screen-Not Docked Status Therapy On/Off andtelemetry success: Start Screen-Not Docked with Therapy On/Off icon onstatus line (Table 17-22) Therapy On/Off and telemetry event: Refer toTable 18 Start Charge and antenna temperature OK: Wait Screen (Table17-1) Start Charge and antenna too hot: Antenna Too Hot Message (Table17-30) Stop Charge: no change Attach DTC: INSR Charge Status

-   -   14—INSR Recharge Complete Message    -   Screen Entry: User Control/System Event        -   INSR recharge complete

Entry Screen User Control/System Event: Next Screen INSR Audio key:Start Screen-Docked Charge Status Therapy On/Off and telemetry success:Start Screen-Docked with Therapy On/Off icon on status line (Table17-22) Therapy On/Off and telemetry event: Refer to Table 18 StartCharge and antenna temperature OK: Wait Screen (Table 17-1) Start Chargeand antenna too hot: Antenna Too Hot Message (Table 17-30) Stop Charge:no change Detach DTC: Start Screen-Not Docked

-   -   Screen Entry: User Control/System Event        -   Attach DTC

Entry Screen User Control/System Event: Next Screen Power Down Audiokey: Start Screen-Docked Start Therapy On/Off and telemetry success:Start Screen-Docked Screen-Not with Therapy On/Off icon on status line(Table 17-22) Docked Therapy On/Off and telemetry event: Refer to Table18 Start Charge and antenna temperature OK: Wait Screen (Table 17-1)Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)Stop Charge: no change Detach DTC: Start Screen-Not Docked

-   -   15—INSR System Information Message    -   Screen Entry: User Control/System Event        -   Audio+Stop Charge

Entry Screen User Control/System Event: Next Screen Power Down Audiokey: Cycle through information Start Screen-Not Stop Charge or Systemtimeout and not docked: Docked Start Screen-Not Docked Start Screen-Stop Charge or System timeout and docked: Docked Start Screen-DockedTherapy On/Off and telemetry success: Start Screen-Not Docked withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry event: Refer to Table 18 Start Charge and antenna temperatureOK: Wait Screen (Table 17-1) Start Charge and antenna too hot: AntennaToo Hot Message (Table 17-30) Attach/Detach DTC: no change

-   -   16—Call Your Doctor—ERI Message    -   Screen Entry: User Control/System Event        -   Therapy On/Off

Entry Screen User Control/System Event: Next Screen Power Down Audio keyor system timeout: Start Screen-Not Docked Start with Therapy On/Officon on status line (Table 17-22) Screen-Not Therapy On/Off andtelemetry success: Start Docked Screen-Not Docked with Therapy On/Officon on status line (Table 17-22) Therapy On/Off and telemetry event:Refer to Table 18 Start Charge and antenna temperature OK: Wait Screen(Table 17-1) Start Charge and antenna too hot: Antenna Too Hot Message(Table 17-30) Stop Charge/Attach DTC: no change INS Charge Audio key orsystem timeout: previous screen with Status Therapy On/Off icon onstatus line (Table 17-22) INS Charge Therapy On/Off and telemetrysuccess: previous Status- screen with Therapy On/Off icon on 90 to 100%status line (Table 17-22) INS Charge Therapy On/Off and telemetry event:Refer to Table 18 Status- Start Charge and antenna temperature OK:Antenna Wait Screen (Table 17-1) Too Hot Start Charge and antenna toohot: INS Charge Status-Antenna Too Hot Screen (Table 17-13) Stop Chargeand not docked: Start Screen-Not Docked Stop Charge and docked: StartScreen-Docked Attach DTC/Detach DTC: no change INSR Charge Audio key orsystem timeout: INSR Charge Status Status Screen with Therapy On/Officon on status line (Table 17-22) Therapy On/Off and telemetry success:INSR Charge Status with Therapy On/Off icon on status line (Table 17-22)Therapy On/Off and telemetry event: Refer to Table 18 Start Charge andantenna temperature OK: Wait Screen (Table 17-1) Start Charge andantenna too hot: Antenna Too Hot Message (Table 17-30) StopCharge/Detach DTC: no change Start Audio key or system timeout: StartScreen-Docked with Screen-Docked Therapy On/Off icon on status line(Table 17-22) Therapy On/Off and telemetry success: Start Screen-Dockedwith Therapy On/Off icon on status line (Table 17-22) Therapy On/Off andtelemetry event: Refer to Table 18 Start Charge and antenna temperatureOK: Wait Screen (Table 17-1) Start Charge and antenna too hot: AntennaToo Hot Message (Table 17-30) Stop Charge/Detach DTC: no change

-   -   Call Your Doctor—ERI continued    -   Screen Entry: User Control/System Event        -   INS error: ERI

Entry Screen User Control/System Event: Next Screen Wait Screen Audiokey or system timeout: Wait Screen Therapy On/Off and telemetry success:Wait Screen Therapy On/Off and telemetry event: Refer to Table 18 StartCharge and antenna temperature OK: Wait Screen (Table 17-1) Start Chargeand antenna too hot: INS Charge Status-Antenna Too Hot Screen (Table17-13) Stop Charge/Attach DTC/Detach DTC: no change INS Charge Audio keyor system timeout: previous screen Status Therapy On/Off and telemetrysuccess: INS Charge previous screen with Status- Therapy On/Off icon onstatus line (Table 17-22) 90 to 100% Therapy On/Off and telemetry event:Refer to Table 18 INS Charge Start Charge and antenna temperature OK:Wait Status- Screen (Table 17-1) Antenna Too Start Charge and antennatoo hot: INS Charge Hot Status-Antenna Too Hot Screen (Table 17-13) StopCharge and not docked: Start Screen-Not Docked Stop Charge and docked:Start Screen-Docked Attach DTC/Detach DTC: no change

-   -   17—Call Your Doctor—POR Message    -   Screen Entry: User Control/System Event        -   Therapy On/Off

Entry Screen User Control/System Event: Next Screen Power Down Audio keyor system timeout: Start Screen-Not Docked Start Screen-Not with TherapyOn/Off icon on status line (Table 17-22) Docked Therapy On/Off: nochange Start Charge/Stop Charge/Attach DTC/Detach DTC: no change INSCharge Status- Audio key or system timeout: previous screen with TherapyINS Charge Status- On/Off icon on status line (Table 17-22) 90 to 100%Therapy On/Off: no change INS Charge Status- Stop Charge and not docked:Start Screen-Not Docked Antenna Too Hot Stop Charge and docked: StartScreen-Docked Start Charge/Attach DTC/Detach DTC: no change INSR ChargeStatus Audio key or system timeout: INSR Charge Status Screen withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off: nochange Start Charge/Stop Charge/Attach DTC/Detach DTC: no change StartScreen-Docked Audio key or system timeout: Start Screen-Docked withTherapy On/Off icon on status line (Table 17-22) Therapy On/Off: nochange Start Charge/Stop Charge/Attach DTC/Detach DTC: no change

-   -   Screen Entry: User Control/System Event        -   INS error: POR

Entry Screen User Control/System Event: Next Screen Wait Screen Audiokey or system timeout: Wait Screen Therapy On/Off and telemetry success:Wait Screen Therapy On/Off and telemetry event: Refer to Table 18 StartCharge and antenna temperature OK: Wait Screen (Table 17-1) Start Chargeand antenna too hot: Antenna Too Hot Message (Table 17-30) StopCharge/Attach DTC/Detach DTC: no change INS Charge Status Audio key orsystem timeout: previous screen INS Charge Status- Therapy On/Off andtelemetry success: previous screen with 90 to 100% INS Therapy On/Officon on status line (Table 17-22) Charge Status- Therapy On/Off andtelemetry event: Refer to Table 18 Antenna Too Hot Stop Charge and notdocked: Start Screen-Not Docked Stop Charge and docked: StartScreen-Docked Start Charge/Attach DTC/Detach DTC: no change

-   -   18—Antenna Too Hot Message    -   Screen Entry: User Control/System Event        -   Start Charge

Entry Screen User Control/System Event: Next Screen Power Down Audio keyor system timeout and not docked and antenna too Start Screen- hot:Start Screen-Not Docked Docked Audio key or system timeout and dockedand antenna too hot: Start Screen-Not Start Screen-Docked Docked Audiokey or system timeout and docked/not docked and INSR Charge antennacools: INS Charge Status/INS Charge Status-90 to Status 100% INS BatteryLow Therapy On/Off and telemetry success and not docked: Start INSRecharge Screen-Not Docked with Therapy On/Off icon on status lineInterrupted (Table 17-22) INS Recharge Therapy On/Off and telemetrysuccess and docked: Start Complete Screen-Docked with Therapy On/Officon on status line INSR Battery Low (Table 17-22) INSR Recharge TherapyOn/Off and telemetry event: Refer to Table 18 Interrupted Start Charge:no change INSR Recharge Stop Charge and charge complete: INS RechargeComplete Complete Message (Table 17-6) Call Your Doctor- Stop Charge andcharge incomplete and not INS battery low: ERI INS Recharge InterruptedMessage (Table 17-5) Call Your Doctor- Stop Charge and INS battery low:INS Battery Low Message Entry Screen User Control/System Event: NextScreen POR Reposition (Table 17-3) Antenna-Press Stop Charge and INSbattery depleted: Recharge Stimulator Start Charge Warning (Table 17-4)Warning Attach/detach DTC: no change Connect INSR Antenna

-   -   19—Warning Messages

Warning User Control/System Event: Next Screen Recharge Stimulator StartCharge and antenna temperature OK: Wait Screen Table 17-1) Start Chargeand antenna too hot: Antenna Too Hot Message (Table 17-30) Systemtimeout: Power Down Recharge INSR Attach DTC: INSR Charge Status Screenwith Power Source Symbol System timeout: Power Down Reposition Antenna-Start Charge and antenna temperature OK: Wait Screen (Table Press StartCharge 17-1) Start Charge and antenna too hot: Antenna Too Hot Message(Table 17-30) System timeout: Power Down Reposition Antenna- Therapy Offand telemetry success: Start Screen-Docked or Press Therapy Off StartScreen-Not Docked with Therapy Off icon on status line (Table 17-22)Therapy Off and telemetry event: refer to Table 18 System timeout: PowerDown Reposition Antenna- Therapy On and telemetry success: StartScreen-Docked or Press Therapy On Start Screen-Not Docked with TherapyOn icon on status line (Table 17-22) Therapy On and telemetry event:refer to Table 18 System timeout: Power Down Call Your Doctor Systemtimeout: Power Down Call Your Doctor- System timeout: Power Down EOS

-   -   20—Splash Screen    -   Screen Entry: User Control/System Event        -   Application is loading        -   Reset button is activated and application is reloading    -   Processing Requirements        -   All keys active        -   Software will display the screen until the user presses any            key or the system times out.        -   When the user presses any key or the system times out,            software will display the Start Screen—Docked or Start            Screen—Not Docked (Table 17-29)    -   21—Connect INSR Antenna Message    -   Screen Entry: User Control/System Event        -   Antenna disconnected

User Control/System Event: Next Screen assuming antenna Entry Screen andrecharger are making full contact) Wait Screen Audio key or systemtimeout and not docked: Start Screen- INS Charge Status Not DockedScreen Audio key or system timeout and docked: Start Screen- INS ChargeStatus- Docked 90 to 100% Therapy On/Off and telemetry success and notdocked: Start Screen-Not Docked with Therapy On/Off icon on status line(Table 17-22) Therapy On/Off and telemetry success and docked: StartScreen-Docked with Therapy On/Off icon on status line (Table 17-22)Therapy On/Off and telemetry event: Refer to Table 18 Start Charge andantenna temperature OK: Wait Screen (Table 17-1) Start Charge andantenna too hot: INS Charge Status- Antenna Too Hot Screen (Table 17-13)Stop Charge: no change Attach/detach DTC: no change Physician RechargeAudio key or system timeout and not docked: Start Screen- Screen NotDocked Physician Recharge Audio key or system timeout and docked: StartScreen- Screen-Antenna Docked Too Hot Therapy On/Off: no change StartCharge: no change Stop Charge: no change Attach/detach DTC: no change

-   -   Screen Entry: User Control/System Event        -   Therapy On/Off        -   Start Charge

User Control/System Event: Next Screen (assuming antenna Entry Screenand recharger are making full contact) All screens and Audio key orsystem timeout and not docked: Start Screen- messages with the NotDocked exception of Audio key or system timeout and docked: StartScreen- Physician Recharge Docked Screen, Physician Therapy On/Off andtelemetry success and not docked: Start Recharge- Screen-Not Docked withTherapy On/Off icon on status line Antenna Too Hot (Table 17-22) Screen,IR Therapy On/Off and telemetry success and docked: Start CommunicationScreen-Docked with Therapy On/Off icon on status line Screen, Splash(Table 17-22) Screen and all Therapy On/Off and telemetry event: Referto Table 18 reposition antenna Start Charge and antenna temperature OK:Wait Screen (Table warnings 17-1) Start Charge and antenna too hot:Antenna Too Hot Message (Table 17-30) Stop Charge: no changeAttach/detach DTC: no change

-   -   22—INS Charge Status—90 to 100% Screen    -   Screen Entry: User Control/System Event        -   System timeout or message clear        -   Antenna temperature OK        -   Battery voltage indicates 90%

User Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Therapy On/Off icon onstatus line Table 17-22) Telemetry event: refer to Table 18 Start ChargeStart Charge and antenna temperature OK: Wait Screen (Table 17-1) StartCharge and antenna too hot: INS Charge Status- Antenna Too Hot Screen(Table 17-13) Stop Charge INS Recharge Complete Message (Table 17-6)Audio Toggle Audio icon (Table 17-24) Attach DTC Power source symbol onstatus line (Table 17-23) Detach DTC INSR battery low: INSR Battery LowMessage (Table 17-8) INSR battery depleted: Recharge INSR Warning (Table17-9) Status line without power source symbol (Table 17-23) INS rechargecomplete INS Recharge Complete Message (Table 17-6) INS error: ERI CallYour Doctor ERI Message (Table 17-19) INS error: POR Call YourDoctor-POR Message (Table 17-27) INS error: EOS, battery Call YourDoctor Warning (Table 17-18) voltage too high Antenna too hot INS ChargeStatus-Antenna Too Hot (Table 17-13) Antenna failure Call Your DoctorWarning (Table 17-18) Antenna disconnected Connect INSR Antenna Message(Table 17-14) INSR battery low INSR Battery Low Message (Table 17-8)INSR battery depleted Recharge INSR Warning (Table 17-9) INSR rechargeINSR Batt1 on status line (Table 17-25) complete System error Call YourDoctor Warning (Table 17-18) Audio + Stop Charge No change Audio + StartCharge No change and hold for > 10 seconds

-   -   23—INS Charge Status—Antenna Too Hot Screen    -   Screen Entry: User Control/System Event        -   Antenna too hot        -   System timeout or message clear

User Control/ System Event System Response: Feedback/Next Screen(requirement) Therapy On/Off Telemetry success: Therapy On/Off icon onstatus line (Table 17-22) Telemetry event: refer to Table 18 StartCharge Start Charge and antenna temperature OK: Wait Screen Table 17-1)Start Charge and antenna too hot: INS Charge Status- Antenna Too HotScreen (Table 17-13) Stop Charge Not docked: Start Screen-Not DockedDocked and INSR recharge complete: INSR Recharge Complete Message (Table17-11) Docked and INSR recharge incomplete: INSR Charge Status Screen(Table 17-7) Audio Toggle Audio icon (Table 17-24) Attach DTC Powersource symbol on status line (Table 17-23) Detach DTC INSR battery low:INSR Battery Low Message (Table 17-8) INSR battery depleted: RechargeINSR Warning (Table 17-9) Status line without power source symbol (Table17-23) INS error: ERI Call Your Doctor ERI Message (Table 17-19) INSerror: POR Call Your Doctor-POR Message (Table 17-27) INS error: EOS,battery Call Your Doctor Warning (Table 17-18) voltage too high Antennatoo hot INS Charge Status-Antenna Too Hot (Table 17-13) Antenna cooledWait Screen/INS Charge Status (Table 17-1) Antenna failure Call YourDoctor Warning (Table 17-18) Antenna disconnected Connect INSR AntennaMessage (Table 17-14) INSR battery low INSR Battery Low Message (Table17-8) INSR battery depleted Recharge INSR Warning (Table 17-9) INSRrecharge INSR Batt1 on status line (Table 17-25) complete System errorCall Your Doctor Warning (Table 17-18) Audio + Stop Charge No changeAudio + Start Charge No change and hold for > 10 seconds

-   -   24—Physician Recharge—Antenna Too Hot Screen    -   Screen Entry: User Control/System Event        -   Antenna too hot

User Control/ System Event* System Response: Feedback/Next Screen(requirement) Successful INS Charge Status Screen (Table 17-2)communication with INS Timer goes to zero and Start Screen-Not Dockedwithout Therapy On/Off icon on system times out (not status line (Table17-22) docked) Timer goes to zero and INSR recharge incomplete: INSRCharge Status Screen system times out (Table 17-7) (docked) INSRrecharge complete: INSR Recharge Complete Message (Table 17-11) StopCharge (not Start Screen-Not Docked docked) Stop Charge (docked) StartScreen-Docked Detach DTC INSR battery low: INSR Battery Low Message(Table 17-8) INSR battery depleted: Recharge INSR Warning (Table 17-9)Antenna too hot Physician Mode-Antenna Too Hot (Table 17-31) Antennafailure Call Your Doctor Warning (Table 17-18) Antenna disconnectedConnect INSR Antenna Message (Table 17-14) System error Call Your DoctorWarning (Table 17-18) INSR battery low INSR Battery Low Message (Table17-8) INSR battery depleted Recharge INSR Warning (Table 17-9) INSRrecharge No change complete *Note: all keys inactive except Stop Charge

TABLE 6 1-When the user presses start charge or the antenna has cooled,software will display the Wait Screen until successful communicationwith the INS is established. . 2-Software will display the INS ChargeStatus Screen as soon as successful communication with the INS isestablished. 3-Display INS Battery Low Message 4-Display RechargeStimulator Warning 5-Display INS Recharge Interrupted Message 6-DisplayINS Recharge Complete Message 7-Display INSR Charge Status Screen8-Display INSR Battery Low Message 9-Display Recharge INSR Warning10-Display INSR Recharge Interrupted Message 11-Display INSR RechargeComplete Message 12-Display Reposition Antenna Press Start ChargeWarning 13-Display INS Charge Status-Antenna Too Hot Screen 14-DisplayConnect INSR Antenna Message 15-Display Reposition Antenna Press TherapyOn Warning 16-Display Reposition Antenna Press Therapy Off Warning17-Display INSR System Information Message 18-Display Call Your DoctorWarning 19-Display Call Your Doctor-ERI Message 20-Entry intentionallyleft blank to preserve numbering 21-Display Physician Recharge Screen22-Software will display an indicator for stimulation status (On/Off) onthe status line. 23-Software will display the power source symbol whenthe desktop charger is docked. 24-Software will display an indicator foraudio control on the status line. 25-Software will display the INSRcharge level on the status line. 26-Software will update the rechargeefficiency line each time user presses Start Charge. 27-Display CallYour Doctor-POR Message 28-Display IR Communication Screen 29-DisplaySplash Screen 30-Display Antenna Too Hot Message 31-Display PhysicianRecharge-Antenna Too Hot Screen

TABLE 7 Therapy On/Off Events System Event Next Screen (requirement) 1.Telemetry failure for Therapy On Reposition Antenna-Press Therapy OnWarning (Table 17-15) 2. Telemetry failure for Therapy Off RepositionAntenna-Press Therapy Off Warning (Table 17-16) 3. INS battery low INSBattery Low Message (Table 17-3) 4. INS battery depleted or in sleepmode Recharge Stimulator Warning (Table 17-4) 5. INS error-ERI Call YourDoctor-ERI Message (Table 17- 19) 6. INS error-POR Call Your Doctor-PORMessage (Table 17-27) 7. INS error-EOS or battery voltage too Call YourDoctor Warning (Table 17-18) high 8. INSR battery low INSR Battery LowMessage (Table 17-8) 9. INSR battery depleted Recharge INSR Warning(Table 17-9) 10. Antenna failure Call Your Doctor Warning (Table 17-18)11. Antenna disconnected Connect INSR Antenna Message (Table 17- 14) 12.System error Call Your Doctor Warning (Table 17-18) 13. Antenna too hotDisplay INS Charge Status-Antenna Too Hot Screen (Table 17-13) orAntenna Too Hot Message (Table 17-30)

User familiarity with both external programming unit 2 and charging unit50 is enhanced through the use of common patient controls and/or displayicons across both devices. The user is presented with common controlsand displays across both platforms.

The primary purpose of external programming unit 2 is to manipulatetherapeutic programs such as starting therapy and stopping therapy. Theprimary purpose of charging unit 50 is to charge or rechargerechargeable power source 24. However, patients may want to controltheir therapy while charging unit 50 is charging the rechargeable powersource 24 of implantable medical device 16. Thus, charging unit 50 isalso equipped with controls to start and stop therapy as well ascontrols to start and stop charging.

External programming unit 2 and charging unit 50 both have similar“Therapy On” controls as illustrated in Table 1 and Table 11,respectively. Similarly, both external programming unit 2 and chargingunit 50 also have similar “Therapy Off” controls as illustrated in Table1 and Table 11, respectively.

To aid in familiarity by the user, both external programming unit 2 andcharging unit 50 also have similar or identical icons to display thesame or similar messages to the user. Battery charging level icons “INSRBatt 1”, “INSR Batt 2”, “INSR Batt 3”, “INSR Batt 4” and “INSR Batt 5”icons are similar or identical between external programming unit 2 andcharging unit 50 as illustrated in Table 1 and Table 11, respectively.

Similarly, the “Call Doctor” icon illustrated in Table 5 with respect toexternal programming unit 2 is the same as, or very nearly the same as,the “Call Doctor” icon illustrated in Table 15 with respect to chargingunit 50.

The “Warnings” icon illustrated in Table 5 with respect to externalprogramming unit 2 is the same as, or very nearly the same as, the“Warnings” icon illustrated in Table 16 with respect to charging unit50.

“Audio On” and “Audio Off” icons illustrated in Table 6 with respect toexternal programming unit 2 are the same as, or very nearly the same as,the “Audio On” and “Audio Off” icons illustrated in Table 11 withrespect to charging unit 50.

These are examples of controls and icons that are the same, or verysimilar, between both platforms, the external programming unit 2 and thecharging unit 50 to aid in user familiarity.

As noted with respect to FIG. 17 describing the process of chargingrechargeable power source 24 using external charging device 48, chargingunit 50 receives information via telemetry from implantable medicaldevice 16 during the charging process. External antenna 52 contains bothprimary coil 54 and external telemetry coil 46 and implantable medicaldevice 16 contains both secondary coil 34 and internal telemetry coil44. When external antenna 52 is positioned properly at or near the siteof implantable medical device 16, primary coil 54 can be inductivelycoupled to secondary coil 34 to facilitate the charging process.Similarly, external telemetry coil 46 can be coupled with internaltelemetry coil 44 to communicate information across cutaneous boundary38 during the charging process.

Also as noted above, magnetic shield 36 prevent electromagneticradiation stimulating secondary coil 34 from reaching the interior ofhousing 32 of implantable medical device. However, external telemetrycoil 46 and internal telemetry coil 44 are sized to be larger thanmagnetic shield 36 allowing electromagnetic communication betweenexternal telemetry coil 46 and internal telemetry coil 44.

At step 112 of the charging process illustrated in FIG. 17, a check ismade to determine if telemetry between charging unit 50 and implantablemedical device 16. Further, the status of charging rechargeable powersource 24 is communicated from implantable medical device 16 anddisplayed by charging unit 50 (step 118). The charging status displayedby charging unit 50 can be the actual known charging status ofrechargeable power source 24 as communicated from implantable medicaldevice 16 to charging unit 50. This prevents essentially guessing theinternal charging status of rechargeable power source 24 by someexternal means such as simply by the passage of time. Rather, the actualcharging status of rechargeable power source 24, e.g., the batteryvoltage, can be measured and transmitted to charging unit 50 for displayto the user.

Typically, inductive charging and telemetry operations are time divisionmultiplexed during the charging operation. That is, a portion of thetime during which charging occurs is dedicated to telemetry. During thisdedicated telemetry time, the inductive charging by primary coil 54 tosecondary coil 34 is momentarily stopped and telemetry allowed to occur.As soon as telemetry has occurred and the required information has beencommunicated, inductive coupling can be resumed. Typically, only arelatively small portion of the time period during charging is requiredto be devoted to telemetry. Inductive charging can be stopped only for ashort, e.g., a few seconds, to allow for telemetry and then inductivecharging can be resumed. Although the time division multiplexing occursover the entire charging period, only a small portion of the chargingtime is lost to telemetry. Time division multiplexing of inductivecoupling charging and telemetry prevents the possibility of inductivecharging from interfering with telemetry signals.

Thus, embodiments of the user interface for external charger forimplantable medical device are disclosed. One skilled in the art willappreciate that the present invention can be practiced with embodimentsother than those disclosed. The disclosed embodiments are presented forpurposes of illustration and not limitation, and the present inventionis limited only by the claims that follow.

What is claimed is:
 1. An implantable medical device system, comprising:an implantable medical device having a secondary coil, said implantablemedical device being configured to communicate transcutaneously usingtelemetry; and an external unit comprising a primary coil configured toinductively transfer energy to said secondary coil of said implantablemedical device when said primary coil is externally placed in proximityof said secondary coil and said external unit drives said primary coil;said external unit being configured to communicate with said implantablemedical device by way of telemetry during the process of transferring,via said primary coil, energy to said implantable medical device;wherein said external unit is configured to time division multiplexbetween said telemetry and said process of transferring energy.
 2. Theimplantable medical device system as m claim 1 wherein said externalunit comprises circuitry and wherein said circuitry of said externalunit drives said primary coil to inductively transfer energy to saidimplantable medical device.
 3. The implantable medical device system asin claim 1 wherein said external unit is configured to be attachable tosaid primary coil.
 4. The implantable medical device system as in claim3 wherein said external unit is configured to be attachable to saidprimary coil by a cord.
 5. The implantable medical device system as inclaim 1 wherein said external unit further comprises a telemetry coiland wherein said external unit is configured to communicate with saidimplantable medical device through said telemetry coil.
 6. The system asin claim 1 wherein said implantable medical device has a rechargeableenergy storage device and wherein said external unit charges saidrechargeable energy storage device.
 7. The system as in claim 1 whereinsaid external unit comprises a display configured to display informationregarding said system.
 8. The system as in claim 2 wherein said externalunit comprises a rechargeable power source operatively coupled to saidcircuitry of said external unit.
 9. The system as in claim 1 whereinsaid external unit is configured to be operated with only two inputbuttons.
 10. The system as in claim 1 wherein said external unit isconfigured to be operated with an external power source.
 11. An externalenergy transfer system configured to transcutaneously transfer energy toan implantable medical device, said implantable medical device capableof receiving inductively coupled energy with a secondary coil and beingcapable of communicating transcutaneously using telemetry, comprising:an external unit having a primary coil, said external unit configured toinductively transfer energy to said secondary coil of said implantablemedical device when said primary coil is externally placed in proximityof said secondary coil and said external unit is driving said primarycoil; and said external unit being configured to communicate with saidimplantable medical device by way of telemetry during the process oftransferring, via said primary coil, energy to said implantable medicaldevice; wherein said external unit is configured to time divisionmultiplex between said telemetry and said process of transferringenergy.
 12. The external energy transfer system as in claim 11 whereinsaid external unit comprises circuitry and wherein said circuitry ofsaid external unit drives said primary coil to inductively transferenergy to said implantable medical device.
 13. The external energytransfer system as in claim 11 wherein said external unit is configuredto be attachable to said primary coil.
 14. The energy transfer system asin claim 13 wherein said external unit is configured to be attachable tosaid primary coil by a cord.
 15. The energy transfer system as in claim14 wherein said external unit further comprises a telemetry coil andwherein said external unit is configured to communicate with saidimplantable medical device through said telemetry coil.
 16. The externalenergy transfer system as in claim 14 wherein said implantable medicaldevice has a rechargeable energy storage device and wherein saidexternal unit charges said rechargeable energy storage device.
 17. Theexternal energy transfer system as in claim 14 wherein said externalunit comprises a display configured to display information regardingsaid system.
 18. The external energy transfer system as in claim 52wherein said external unit comprises a rechargeable power sourceoperatively coupled to said circuitry of said external unit.
 19. Theexternal energy transfer system as in claim 11 wherein said externalunit is configured to be operated with only two input buttons.
 20. Theexternal energy transfer system as in claim 11 wherein said externalunit is configured to be operated with an external power source.
 21. Amethod of interacting with an implantable medical device, saidimplantable medical device capable of receiving inductively coupledenergy with a secondary coil and being capable of communicatingtranscutaneously using telemetry, comprising the steps of: inductivelytransferring energy to said secondary coil with an external unit havinga primary coil when said primary coil is externally placed in proximityof said secondary coil; driving said primary coil with an external unitto inductively transfer energy to said implantable medical device; andcommunicating between said external unit and said implantable medicaldevice through telemetry; wherein time division multiplexing occursbetween said telemetry and said inductively transferring energy.
 22. Themethod as in claim 21 wherein said driving step further comprisesdriving said primary coil with circuitry of said external unit toinductively transfer energy to said implantable medical device.
 23. Themethod as in claim 21 wherein said external unit is configured to beattachable to said primary coil.
 24. The method as in claim 23 whereinsaid external unit is configured to be attachable to said primary coilby a cord.
 25. The method as in claim 21 wherein said external unitfurther comprises a telemetry coil and wherein communicating betweensaid external unit and said implantable medical device comprisescommunicating during said inductively transferring step, between saidtelemetry coil of said external unit and said implantable medicaldevice.
 26. The method as in claim 22 wherein said external unitcomprises a rechargeable power source operatively coupled to saidcircuitry of said external unit.
 27. The method as in claim 21 whereinsaid implantable medical device has a rechargeable energy storage deviceand wherein said external unit charges said rechargeable energy storagedevice.
 28. The method as in claim 21 further comprising the step ofdisplaying information regarding said system using a display.
 29. Themethod as in claim 21 wherein said external unit is configured to beoperated with only two input buttons.
 30. The method as in claim 21wherein said external unit is configured to be operated with an externalpower source.